دورية أكاديمية
Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2–Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study
| العنوان: | Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2–Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study |
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| المؤلفون: | Nakamura, Yoshiaki, Mizuno, Nobumasa, Sunakawa, Yu, Canon, Jean-Luc, Galsky, Matthew D., Hamilton, Erika, Hayashi, Hidetoshi, Jerusalem, Guy, Kim, Seung Tae, Lee, Keun-Wook, Kankeu Fonkoua, Lionel Aurelien, Monk, Bradley J., Nguyen, Danny, Oh, Do-Youn, Okines, Alicia, O'Malley, David M., Pohlmann, Paula, Reck, Martin, Shin, Sang Joon, Sudo, Kazuki, Takahashi, Shunji, van Marcke, Cédric, Yu, Evan Y., Groisberg, Roman, Ramos, Jorge, Tan, Sherry, Stinchcombe, Thomas E., Bekaii-Saab, Tanios |
| المساهمون: | UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale |
| المصدر: | Journal of Clinical Oncology, Vol. 9, no.1, p. 1-10 (2023) |
| بيانات النشر: | American Society of Clinical Oncology (ASCO) |
| سنة النشر: | 2023 |
| المجموعة: | DIAL@USL-B (Université Saint-Louis, Bruxelles) |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | Purpose: To evaluate the efficacy and safety of tucatinib and trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) metastatic biliary tract cancer (mBTC). Methods: SGNTUC-019 (ClinicalTrials.gov identifier: NCT04579380) is an open-label phase II basket study evaluating the efficacy and safety of tucatinib and trastuzumab in patients with HER2-altered solid tumors. In the biliary tract cancer cohort, patients had previously treated HER2 overexpressing or amplified (HER2+) tumors (identified with local testing) with no prior HER2-directed therapy. The primary end point was confirmed objective response rate (cORR) per investigator assessment. Patients were treated on a 21-day cycle with tucatinib (300 mg orally twice daily) and trastuzumab (8 mg/kg intravenously followed by 6 mg/kg every 3 weeks). Results: Thirty patients were enrolled. As of data cutoff (January 30, 2023), the median duration of follow-up was 10.8 months. The cORR was 46.7% (90% CI, 30.8 to 63.0), with a disease control rate of 76.7% (90% CI, 60.6 to 88.5). The median duration of response and progression-free survival were 6.0 months (90% CI, 5.5 to 6.9) and 5.5 months (90% CI, 3.9 to 8.1), respectively. At data cutoff, 15 patients (50.0%) had died, and the estimated 12-month overall survival rate was 53.6% (90% CI, 36.8 to 67.8). The two most common treatment-emergent adverse events (TEAEs) were pyrexia (43.3%) and diarrhea (40.0%). Grade ≥3 TEAEs were reported in 18 patients (60.0%), with the most common being cholangitis, decreased appetite, and nausea (all 10.0%), which were generally not treatment related. TEAEs led to treatment regimen discontinuation in one patient, and there were no deaths due to TEAEs. Conclusion: Tucatinib combined with trastuzumab had clinically significant antitumor activity and was well tolerated in patients with previously treated HER2+ mBTC. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0732-183X 1527-7755 |
| العلاقة: | boreal:281062; http://hdl.handle.net/2078.1/281062Test; urn:ISSN:0732-183X; urn:EISSN:1527-7755 |
| DOI: | 10.1200/jco.23.00606 |
| الإتاحة: | https://doi.org/10.1200/jco.23.00606Test http://hdl.handle.net/2078.1/281062Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.7FA48010 |
| قاعدة البيانات: | BASE |
| تدمد: | 0732183X 15277755 |
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| DOI: | 10.1200/jco.23.00606 |